NDSC Position Statement on Sicca Cell Therapy

Down Syndrome News
The Newsletter of the National Down Syndrome Congress
January/February 1986
  Up-dated and approved by the National Down Syndrome Congress Board of Directors
April 2, 1989

     The use of animal cell preparations by injection to attempt modification of various human disorders has gone on for many decades. The most extensive of these efforts and the one usually discussed in relation to Down syndrome is so-called "sicca cell therapy." This involves the subcutaneous or intramuscular injections of saline suspensions of previously freeze-dried fetal calf cells from the brain and other organs. The materials under discussion are prepared in West Germany, have not been approved by the FDA and are illegal for administration in the United States. Hence, procurement of these regimens ordinarily involves travel to Germany, Switzerland or Canada for injections.

     Leading proponents of sicca cell therapy claim that enzymes and other biochemical substances which are present in the injections provide stimulant and replacement actions which affect growth, learning, language, physical appearance, resistance to infection and vitality. It is stated that several thousand children with Down syndrome from various countries have been enrolled in courses of treatment, usually early in life and in multiple administrations at intervals of five-to-six months. The impressions of families who have pursued such programs are frequently favorable (anecdotal reports) though in moderate degree. It is of singular importance that no systematic or rigorous evaluations of the effects of treatment have ever been undertaken and little prospect exists now for the accomplishment of such (controlled, double-blind) studies. The assertion of usefulness given in promotional writings is disarmingly imprecise and entirely unsupported by scientific study. Concurrent with the injections there are usually recommendations for various hormone, vitamin and dietary supplements plus special training programs. These plus the accompanying elements of general support provided make it more difficult to ascertain the specific functions of the cell therapy.

     There is also an incomplete listing available regarding troublesome side effects although some articles admit to local reactions at the injection sites. Fever and generalized allergic responses (occasionally severe) have been reported as well, such as would be expected from the administration of foreign tissue proteins. Of more critical importance, however, is the real possibility that surviving animal viruses will be transmitted in the injections with fatal consequences. The special concern here involves the so-called "slow viruses" which have very prolonged incubation periods (years long) and may not have been apparent in the animal whose tissues were used for the preparation. The potential incidence of this is unknown.

     Because of the risks, the Board of Directors of the National Down Syndrome Congress has issued a statement that it views sicca cell therapy as life-threatening and advises against its use.

  Revised: January 14, 1998.